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510(k) Data Aggregation
K Number
K251931Device Name
BioTraceIO Vision (V1.7)Manufacturer
Date Cleared
2025-09-08
(76 days)
Regulation Number
892.2050Type
TraditionalPanel
RadiologyReference & Predicate Devices
N/A
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Device Name :
BioTraceIO Vision (V1.7)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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